Effects of Alkaline Phosphatase on Renal Function in Septic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-03-31

Brief Summary

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Septic shock is the most common cause of death in patients requiring intensive care. The kidney is one of the first organs to fail, stressing the importance to search for clinical interventions that may protect the kidneys during sepsis.

Alkaline phosphatase functions as a host defence molecule and is present in many cells and organs (e.g. intestine, placenta, liver, kidney and bone). Alkaline phosphatase has a dual mode of action. First, it binds to and, subsequently, dephosphorylates lipopolysaccharide (LPS). Second, the enzymatic reaction product monophosphoryl-LPS is a non-toxic substance for mammals which acts as a partial antagonist on the LPS receptor complex. In several animal studies, administration of alkaline phosphatase attenuates the inflammatory response and reduces mortality.

It is unknown whether these results can be extrapolated to septic patients . We studied the effects of alkaline phosphatse administration on kidney damage and function in patients with severe sepsis or septic shock.

Detailed Description

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Conditions

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Severe Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Proven or suspected Gram-negative bacterial infection
* Two out of four Systemic Inflammatory Response Syndrome (SIRS) criteria existing for less than 24 h
* Acute onset of end-organ dysfunction in the preceding 12 h

Exclusion Criteria

* Prior therapy with alkaline phosphatase
* Known allergy for cow milk
* Probable death within 24 h
* Chronic renal failure requiring hemodialysis or peritoneal dialysis
* Acute pancreatitis with no established source of infection
* HIV seropositive
* Pregnant or lactating
* Confirmed Gram-positive or fungal sepsis
* Treatment with immunosuppressants including high doses of glucocorticosteroids

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Peter Pickkers, MD, PhD

Role: STUDY_DIRECTOR

Radboud University Medical Center

Locations

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Radboud University Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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PP05

Identifier Type: -

Identifier Source: org_study_id